EYE-Mobile TRACKer IN the Diagnosis of Minimal Hepatic Encephalopathy

NCT03732118 | Unknown

• 2 other identifiers: NI17058J2018-A02156-49
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatic encephalopathy (HE) corresponds to the neurological or the neuropsychological symptoms caused by an acute or chronic liver disease and/or porto-systemic shunt. Many patients present neurological symptoms even if their liver disease is stabilized. Furthermore, HE is associated with an altered quality of life and an increased mortality. Its incidence is high with 30 to 80% of cirrhotic patients that will display according to retained diagnostic criteria. HE symptoms are going from subtle neuropsychological abnormalities detected only on neuropsychological testing, minimal HE, to altered consciousness, overt HE. Recently, the therapeutic armamentarium has increased with now several drugs (rifaximin, ammonia lowering agents) that are able to prevent new bouts of HE. Unfortunately, the diagnosis of minimal HE is difficult and no gold-standard is available. None of the proposed test is rapid and easily performed at bedside. Recently, different studies suggest the potential interest of the study of the ocular movements in HE. Abnormalities in ocular saccades could be an early predictor of cortical impairment. In a pilot feasibility study using an eye-tracker, we could show that cirrhotic patients with minimal HE had, compared to healthy controls, increased latencies, decreased speed of voluntary and reflex saccades, more errors in anti-saccades, more anticipations saccades and more difficulties to fix the target. Our hypothesis was that the use of the eye-tracker will enable the diagnosis of minimal HE by studying the characteristics of saccades and anti-saccades. Since no gold-standard is available for the diagnosis of minimal HE, we will use the conclusion of an adjudication committee formed by 2 experts. Their clinical judgment will take into account the results of medical history, clinical examination, neuropsychological testing, PHES, Critical Flicker Frequency test (CFF), ammonemia levels, EEG and brain MRI with spectroscopy.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance (evaluated with the area under the roc curve) associated with the measure of reflex saccads latencies for the diagnostic of minimal HE

  The diagnostic performance of the measure of reflex saccads latencies will be evaluated by the area under the roc curve and its 95% confidence interval

  one day

Secondary Outcomes (14)

• Area under the roc curve associated with the measure of reflex saccads speed for the diagnostic of minimal HE.

  one day

• Association between reflex saccads speed and results of neuropsychological testings

  one day

• Area under the roc curve associated with the measure of reflex saccads gain for the diagnostic of minimal HE

  one day

• Association between reflex saccads gain and results of neuropsychological testings

  one day

• Area under the roc curve associated with the measure of voluntary saccads latency for the diagnostic of minimal HE.

  one day

Study Arms (2)

Minimal hepatic encephalopathy

Device: Eye-tracker Mobile EBT

No hepatic encephalopathy (minimal or clinical)

Device: Eye-tracker Mobile EBT

Interventions

Eye-tracker Mobile EBT DEVICE

Use of the eye-tracker for the diagnosis of minimal HE by studying the characteristics of saccades and anti-saccades during a day hospitalization.

Minimal hepatic encephalopathy; No hepatic encephalopathy (minimal or clinical)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with cirrhosis

You may qualify if:

• Eligibility criteria for EHM+ subjects:
• Age between 18 and 70 (inclusive)
• Cirrhosis
• Minimal hepatic encephalopathy
• Expression of non opposition
• Eligibility criteria for EHM- subjects:
• Age between 18 and 70 (inclusive)
• Cirrhosis
• No hepatic encephalopathy (minimal or clinical)
• Paired with EHM+ subjects about age, gender, MELD score and cirrhosis etiology
• Expression of non opposition

You may not qualify if:

• Age older than 70
• MMS score \< 24
• Clinical hepatic encephalopathy
• Cirrhosis etiology different from alcoholic, viral or metabolic one
• Intake of psychotropic drugs within 48h
• Alcohol intake \> 30 g/j
• Heart, renal or respiratory failure
• Evolutive neurological diseases
• History of neurological diseases causing consequences
• Non corrected visuals disorders
• Oculomotor disorders from any etiology
• Highly-resistant bacteria carrier subjects
• Inability to put on the eye-tracker device

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas WEISS, MD, PhD

  Pitié-Salpêtrière Hospital (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas WEISS, MD, PhD

CONTACT

+33(0)1 42 16 27 70; nicolas.weiss@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 6, 2018
• Study Start: December 18, 2020
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-02

Locations

FR (1)